PRODUCTION METHOD FOR MEDICINAL PREPARATION, AND MEDICINAL PREPARATION KIT

Title:

PRODUCTION METHOD FOR MEDICINAL PREPARATION, AND MEDICINAL PREPARATION KIT

Document Type and Number:

WIPO Patent Application WO/2014/207956

Kind Code:

A1

Abstract:

Provided is a production method for a medicinal preparation comprising a first preparation component and a second preparation component, wherein the method includes: a step of preparing a first preparation component that is an active pharmaceutical ingredient previously demonstrated in non-clinical studies to be stable, effective, and safe, and that comprises an effective component and a solvent only, the effective component being either a protein preparation component, a nucleic acid preparation component, or a vaccine preparation component; a step of preparing a second preparation component which, in the event that the effective component is a protein preparation component or a nucleic acid preparation component, contains at least one type of preparation additive, or in the event that the effective component is a vaccine preparation component, contains at least one type of adjuvant and/or preparation additive; a step in which an adsorption preventive agent is filtered through a filtration sterilization filter to effect adsorption preventive treatment of the filtration sterilization filter; a step of filtration sterilization of the first preparation component through the filtration -sterilization filter; and a step of formulation through mixing the filtration-sterilized first preparation component and the second preparation component in any proportion, making possible administration without the need to evaluate stability in clinical studies.

Inventors:

YASUI KIYOTADA (JP)

Application Number:

PCT/JP2013/081190

Publication Date:

December 31, 2014

Filing Date:

November 19, 2013

Export Citation:

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Assignee:

YASUI KIYOTADA (JP)

International Classes:

A61K38/00; A61K9/08; A61K39/12; A61K39/395; A61K48/00

Domestic Patent References:

WO1989002265A1

1989-03-23

Foreign References:

JP2009514843A	2009-04-09
JP2011500054A	2011-01-06

Other References:

NORIAKI SADAKANE ET AL.: "Chiken Chushayaku Chosei eno Yakuzaishi no Kan'yo", JOURNAL OF JAPANESE SOCIETY OF HOSPITAL PHARMACISTS, vol. 37, no. 12, 2001, pages 71 - 73
JUNJI MAGATA ET AL.: "Roka Mekkin ni Tsuite", INFECTION CONTROL, vol. 11, no. 11, 2002, pages 34 - 38
KYOSUKE TSUDA ET AL.: "Iyakuhin Kaihatsu Kiso Koza XI Yakuzai Seizoho (last volumn", 1971, pages 591 - 596